# K022688: Versabond AB Bone Cement

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Apr 29, 2004 after 625 days
- Product code: LOD (Bone Cement)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K850247 (1985). 14 ancestors in all.
No later device cites it as a predicate yet.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001160: Versabond Bone Cement, Smith & Nephew, Inc. (2000)
- K033509: Modification to Versabond Bone Cement, Smith & Nephew, Inc. (2003). Cleared while this submission was under review Summary page 1.
- K012193: Amc Antimicrobial Pin/Wire Sleeve, Smith & Nephew, Inc. (2002) Summary page 1.
- K030086: Palacos R Bone Cement with Gentamicin, Biomet, Inc. (2003). Cleared while this submission was under review Summary page 1.
- P810020: Palacos R Bone Cement, Smith & Nephew Richards, Inc. (1984) Summary page 1.

## Cited in the summary but kept off the family tree
- P17004: Surgical Simplex P. Number could not be read Summary page 1.

## Recalls of this device
- Dec 18, 2020 · Class II · Z-0933-2021: Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing.

## Indications for use
VersaBond AB Bone Cement with Gentamicin is indicated for the fixation of prostheses to living bone for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

Source page: https://510kreport.com/device/K022688
Methodology: https://510kreport.com/methodology